Our Services
Our Services
Patient Guard is an experienced and well respected Medical Device consultancy. We offer a full range of Medical Device Regulatory & Quality Assurance services. We aim to be a one stop shop for all your compliance needs:
Medical Device Consultancy
Patient Guard has a wealth of experience in assisting customers with their Medical Device compliance needs.
We hold your hand through the whole process and are there to guide you when you need us.
Our consultancy service offers peace of mind to customers, we can offer ongoing support or just as and when needed consultancy support.
PRRC Services
Medical Device and IVD manufacturers who sell into the EU must have a Person Responsible for Regulatory Compliance (PRRC) at their disposal.
This is stated in Article 15 of both the Medical Device Regulation 2017/745 (MDR) and In-vitro Diagnostic Regulation 2017/746 (IVDR).
Patient Guard provides PRRC services to ensure you are compliant with the Medical Device and IVD Regulations.
QMS Services
Having an ISO 13485 compliant Quality Management System (QMS) is an essential requirement for Medical Device Manufacturers, Suppliers and Distributors.
Patient Guard can assist you with all your Quality Assurance needs from implementation of a QMS, to Internal Audits and ongoing support.
UK Responsible Person
Medical Device Manufacturers based outside of the UK must designate a UK Responsible Person (UKRP), as defined in the UK Medical Devices Regulations 2002 (as amended).
As an MHRA registered Responsible Person, Patient Guard is well placed to support you in registering your Medical Devices on the UK market.
EU Authorised Representative
The European Union (EU) requires Medical Device Manufacturers based outside of the EU to appoint an EU Authorized Representative.
As a EUDAMED and German registered Authorised Representative, Patient Guard is well placed to support you in registering your Medical Devices on the EU market.
Biological Evaluation
All Medical Devices which have direct or indirect contact with the user/patient must be evaluated for their biocompatibility.
Patient Guards expert toxicologists can write your Biological Evaluation Plans and Biological Evaluation Reports.
In full compliance with the requirements of ISO 10993 and national regulatory authority guidelines.
Internal Auditing Service
Patient Guard provides an Internal Auditing service for ISO 13485 Quality Management Systems.
This service helps to remove bias from your internal auditing process, allowing easier compliance from Notified Bodies.
CE Mark & UKCA Mark Technical Files
Patient Guard are experts at compiling Technical Files (Medical Device Files) for customers that are fully compliant for the purposes of the EU IVDR and MDR for CE marking, and the UK Medical Device Regulations for the purposes of UKCA marking.
No matter which market you want to enter Patient Guard can help with your technical documentation requirements.
Clinical Evaluation
Patient Guards experts can help you navigate the complexities of the Clinical Evaluation process.
Clinical Evaluation is a critical part of demonstrating Regulatory Compliance.
Clinical Evaluation for CE marking and UKCA marking involves the requirement for a Clinical Evaluation Plan and a Clinical Evaluation Report
PMCF
Post Market Clinical Follow up (PMCF) under EU MDR 2017/745 has become much more important and now covers nearly all medical device types. It is essential that Manufacturers are compliant with PMCF requirements, click below to see how Patient Guard can help,
Vigilance & PMS
Medical Device and IVD requirements for Post Market Surveillance and Vigilance are much stricter than they were a few years go. It is essential that Manufacturers understand their obligations under PMS regulatory requirements. Click to find out more.
Cosmetics Responsible Person
Cosmetic Products placed on the EU and the UK market by manufacturers based outside of those jurisdictions must appoint a Responsible Person. Click to find out more.
